# K031202: Medipalm-20

- Pathway: 510(k) (Traditional)
- Applicant: Braebon Medical Corp.
- Decided: May 1, 2003 after 15 days
- Product code: OLV (Standard Polysomnograph With Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K981445 (1998). 6 ancestors in all.
48 later devices descend from it; 3 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001013: Monet Acquisition System for Eeg and Polysomnography, Airsep Corp. (2000) Summary page 2.
- K003154: Mizar, Basis BE, Sandman Digital, Eb Neuro S.P.A. (2001) Summary page 2.
- K990565: Suzanne, Nellcor Puritan Bennett, Inc. (1999) Summary page 2.
- K001743: Ultima Smartbelt, Model 0560, Braebon Medical Corp. (2000) Summary page 2.
- K984431: Ultima Airflow Pressure Sensor, Braebon Medical Corp. (1998) Summary page 2.

## Cited in the summary but kept off the family tree
- K002690: Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500, Nonin Medical, Inc. (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K073682: Embletta Gold (2008), 41 descendants of its own
- K122516: Embletta MPR (2013), 27 descendants of its own
- K161579: Watch-PAT200U (2017), 20 descendants of its own
- K180775: Watch-PAT300 (2018), 12 descendants of its own
- K090273: Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100 (2009), 7 descendants of its own

## Indications for use
The MEDIPalm-20™ is a portable data recorder used to collect physiological signals for transfer to an FDA-cleared polysomnographic analysis station capable of reading European Data Format (.edf) files.

Source page: https://510kreport.com/device/K031202
Methodology: https://510kreport.com/methodology